Neoadjuvant immunotherapy before surgery for non-small cell lung cancer

Effects of Neoadjuvant Immunotherapy on Patients With Lung Cancer: a Prospective, Observational Study

This project will see if giving immunotherapy before surgery helps adults with non‑small cell lung cancer and whether pneumonectomy, lobectomy, or non‑surgical treatments lead to better long‑term outcomes.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years to 79 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT07166003 on ClinicalTrials.gov

What this trial studies

This observational study follows adults with non‑small cell lung cancer who receive at least two cycles of neoadjuvant immunotherapy and records their subsequent treatments and outcomes. Participants undergo different post‑immunotherapy management—pneumonectomy, lobectomy, or radiotherapy—and investigators will compare long‑term clinical outcomes such as survival, recurrence, and lung function. Eligibility is limited to patients aged 18–79 with ECOG 0 and complete clinical and imaging data, while those with active autoimmune disease, EGFR/ALK‑sensitive mutations, prior anti‑tumor therapy, or severe comorbidities are excluded. The study uses routine clinical data and longitudinal follow‑up to identify differences between surgical approaches and between surgical and non‑surgical modalities after neoadjuvant immunotherapy.

Who should consider this trial

Good fit: Adults aged 18–79 with non‑small cell lung cancer who have received at least two cycles of neoadjuvant immunotherapy, have ECOG 0, and have complete clinical and imaging data are the ideal candidates.

Not a fit: People with active autoimmune disease, EGFR/ALK‑sensitive mutations, prior chemotherapy or radiotherapy, organ transplantation, severe lung disease, uncontrolled diabetes or hypertension, or who are pregnant or breastfeeding are unlikely to be included and may not benefit from the study's findings.

Why it matters

Potential benefit: If successful, the results could help doctors choose the best surgical approach or decide between surgery and non‑surgical options after neoadjuvant immunotherapy, potentially improving survival and quality of life.

How similar studies have performed: Prior neoadjuvant immunotherapy trials in NSCLC have shown encouraging tumor responses and pathologic downstaging, but head‑to‑head observational comparisons of pneumonectomy versus lobectomy or surgery versus radiotherapy after such therapy remain limited.

Eligibility criteria

Inclusion Criteria:

1. Aged between 18 and 79 years;
2. Received at least two cycles of neoadjuvant immunotherapy;
3. ECOG performance status score of 0;
4. Complete clinical information including imaging data available.

Exclusion Criteria:

1. Diagnosed with or suspected active autoimmune diseases;
2. Presence of EGFR/ALK sensitive mutations;
3. Pregnant or breastfeeding women;
4. Previous anti-tumor therapies including chemotherapy or radiotherapy;
5. History of organ transplantation or hematopoietic stem cell transplantation;
6. Interstitial pneumonia, pulmonary fibrosis, or severe emphysema;
7. Uncontrolled diabetes mellitus;
8. Uncontrolled hypertension.

Where this trial is running

Beijing

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Shugeng Gao, MD

Conditions Lung Cancer, Non-Small Cell; Immunotherapy